Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00043719
First received: August 12, 2002
Last updated: January 29, 2009
Last verified: January 2009
  Purpose

Osteopenia and osteoporosis cause thinning of bone tissue and loss of bone density over time. The purpose of this study is to determine the safety and effectiveness of nitroglycerin ointment for the treatment of osteopenia in postmenopausal women.

Study hypothesis: On average, participants in the base therapy cohort who receive placebo ointment control and calcium/vitamin D will lose more bone density than participants in the nitroglycerin cohort over the 36-month period.


Condition Intervention Phase
Osteoporosis
Osteopenia
Drug: Nitroglycerin ointment
Drug: Calcium supplement with vitamin D
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Prevention of Postmenopausal Bone Loss With Nitric Oxide

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:
  • DXA-measured BMD (bone mineral density) of lumbar vertebrae (L2 to L4)

Secondary Outcome Measures:
  • DXA-measured BMD of dual hips (Ward's triangle, femoral neck, and trochanter)
  • serum osteocalcin
  • BS-ALP
  • serum N-telopeptide

Estimated Enrollment: 200
Study Start Date: July 2002
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Imbalance in the activities of osteoclasts (cells responsible for bone loss) and osteoblasts (cells responsible for bone formation) may lead to fractures, osteopenia, and osteoporosis in postmenopausal women. During postmenopause, decreased estrogen levels and decreased nitric oxide production occur; estrogen replacement therapy has been shown to restore serum nitric oxide levels to normal. Reversing nitric oxide deficiency by using nitroglycerin may prevent further bone loss. The Nitroglycerin as an Option: Value in Early Bone Loss (NOVEL) study will test the safety and efficacy of nitroglycerin ointment for the treatment of osteopenia in postmenopausal women.

Patients will be enrolled in the study for 3 years and will be randomly assigned to one of two groups. The first group will receive nitroglycerin ointment, while the second group will receive placebo ointment. All patients will be given a calcium supplement with vitamin D to be taken daily, and will be instructed to rub the given ointment on their skin daily. Study visits will occur at Month 2 and every six months after Month 2. Phone interviews will be conducted with patients every 2 months throughout the study.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postmenopausal for a minimum of 13 months
  • Lumbar spine T-score of 0 to -2.5 (0 to -2.0 if over 60 years old) by Dual Energy X-ray Absorptiometry (DEXA) (i.e., evidence of normal bone mass or osteopenia)
  • Body Mass Index (BMI) between 18 and 32
  • Planning to live in the greater New Brunswick, NJ, area for at least 3 years

Exclusion Criteria:

  • Radiographically or DEXA-morphometrically proven vertebral or hip fracture
  • Conditions requiring routine use of sublingual, transdermal, or oral nitrates
  • Significant postmenopausal symptoms that require estrogen therapy
  • Metabolic bone diseases other than postmenopausal bone loss (e.g., active hyperthyroidism, hyperparathyroidism, Paget's disease of bone, etc.)
  • Insulin-dependent diabetes mellitus
  • Significant migraine headaches
  • History of renal calculi
  • Cancer within 5 years prior to study entry
  • Any condition causing an anticipated life expectancy of less than 3 years
  • Failure to maintain 75% to 125% compliance with open-label calcium with vitamin D regimen during the screening period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043719

Locations
United States, New Jersey
UMDNJ-Robert Wood Johnson Medical School, Department of Medicine, Division of Endocrinology
New Brunswick, New Jersey, United States, 08903-0019
Sponsors and Collaborators
Investigators
Principal Investigator: Sunil J. Wimalawansa, MD, PhD UMDNJ - Robert Wood Johnson Medical School, Division of Endocrinology
  More Information

No publications provided

Responsible Party: Sunil J. Wimalawansa , MD, PhD, UMDNJ - Robert Wood Johnson Medical School, Division of Endocrinology
ClinicalTrials.gov Identifier: NCT00043719     History of Changes
Other Study ID Numbers: R01 AR048679, NIAMS-069, NOVEL
Study First Received: August 12, 2002
Last Updated: January 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Human Female
Osteoporosis
Postmenopausal
Nitric Oxide
Nitroglycerin
Calcium
Vitamin D

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamins
Vitamin D
Nitroglycerin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014